Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)
- Registration Number
- NCT00956436
- Lead Sponsor
- Biogen
- Brief Summary
This is a phase 1b, open-Label study of sorafenib with BIIB022 in subjects with advanced hepatocellular carcinoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Age ≥18 years
- Histologically-confirmed advanced HCC with at least 1 target lesion measurable by modified RECIST.
- Child-Pugh score A5 or A6.
- ECOG Performance Status of ≤2.
Exclusion Criteria
- Known central nervous system or brain metastases.
- Prior anti-IGF-1R therapy.
- Prior systemic therapy for advanced HCC. Prior local therapies are only permitted if subjects have documented disease progression according to modified RECIST.
- Concurrent anticancer therapy.
- History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure.
- Acute hepatitis
- Fibrolamellar HCC
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sorafenib with BIIB022 BIIB022 Sorafenib with BIIB022 Sorafenib Monotherapy Sorafenib Sorafenib Monotherapy
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of BIIB022 given once every 3 weeks in combination with sorafenib in subjects with advanced HCC. 6 months
- Secondary Outcome Measures
Name Time Method To assess the anti-tumor response in this study population 6 months To evaluate the PK profile of BIIB022 and sorafenib in this study population 6 months
Trial Locations
- Locations (1)
Resesarch Site
🇬🇧Edgbaston, Birmingham, United Kingdom
Resesarch Site🇬🇧Edgbaston, Birmingham, United Kingdom